Navigation Links
Strativa Pharmaceuticals Provides Product Pipeline Update
Date:4/9/2009

Files NDA for Ondansetron Orally Dissolving Film Strip

BioAlliance to Resubmit Loramyc(R) NDA

WOODCLIFF LAKE, N.J., April 9 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), today provides an update on two of its pipeline products.

Ondansetron Orally Dissolving Film Strip

On April 7, 2009, Strativa submitted a New Drug Application (NDA) for its new orally dissolving film strips (ODFS) formulation of ondansetron to the U.S. Food and Drug Administration (FDA). Strativa is seeking approval of ondansetron ODFS in 8 mg and 4 mg strengths for the prevention of chemotherapy and radiation-induced nausea and vomiting, and prevention of post-operative nausea and vomiting.

A program consisting of three separate pivotal studies comparing the bioequivalence of ondansetron ODFS 8mg to Zofran ODT(R) 8mg was completed in December 2008 and supports the NDA filing of ondansetron ODFS. The pharmacokinetic results of each study demonstrate that a single dose of ondansetron ODFS, taken with or without water, is bioequivalent to Zofran ODT, taken under similar conditions.

The antiemetic market totaled 4.1 million prescriptions in 2008. Ondansetron was the prescription leader in the category, accounting for 95% of prescriptions.

In June 2008, Strativa acquired the commercialization rights in the United States and its territories to ondansetron ODFS from MonoSol Rx. To date, Strativa has paid MonoSol Rx a total of $3.5 million for the completion of certain milestones.

Loramyc(R) (miconazole Lauriad) for the treatment of oropharyngeal candidiasis (OPC)

After preliminary review, the FDA h
'/>"/>

SOURCE Par Pharmaceutical Companies, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Strativa Pharmaceuticals Announces Phase III Results for Loramyc(R) to Treat Oropharyngeal Candidiasis
2. Strativa Pharmaceuticals Announces Preliminary Results from ONCONASE(R) Phase IIIb Clinical Trial
3. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
4. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
5. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
6. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
7. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
8. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
9. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
10. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
11. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/1/2014)... Calif. , Oct. 1, 2014  SI-BONE, Inc., a ... Implant System, ® a minimally invasive surgical (MIS) device ... joint, today announced the expansion of its European operations with ... Eric Schaber as General Manager, Germany.  Mr. Schaber ... vice president of Europe , ...
(Date:10/1/2014)... , Switzerland , October 1, 2014 ... in Clinical Genomics and Next Generation Sequencing (NGS) data ... clinicians to run full cystic fibrosis analysis in a ... identification and characterisation of all types of variants in ... Until now, it has not been possible ...
(Date:9/30/2014)... Sept. 30, 2014  Hologic, Inc. (NASDAQ: ... Hologic,s President and Chief Executive Officer, will preside over ... 1, the first day of Breast Cancer Awareness Month. ... campaign focused on the important benefits of Hologic,s 3D ... FDA as clinically superior to traditional mammography. ...
Breaking Medicine Technology:SI-BONE, Inc. Announces European Expansion with Appointment of Eric Schaber as General Manager, Germany and Formation of GmbH 2SI-BONE, Inc. Announces European Expansion with Appointment of Eric Schaber as General Manager, Germany and Formation of GmbH 3SI-BONE, Inc. Announces European Expansion with Appointment of Eric Schaber as General Manager, Germany and Formation of GmbH 4Sophia Genetics Launches Full CFTR Analysis in Single Clinical Grade NGS Experiment 2Hologic to Kick Off National Breast Cancer Awareness Month at the October 1 NASDAQ Stock Market Opening Bell Ceremony 2Hologic to Kick Off National Breast Cancer Awareness Month at the October 1 NASDAQ Stock Market Opening Bell Ceremony 3
... Nov. 2, 2010 CareFusion Corp. (NYSE: CFN ... for the three months ended Sept. 30, 2010. ... line with our expectations, and highlighted a strong quarter for ... David Schlotterbeck, chairman and CEO of CareFusion. "In the first ...
... 2010 Fiscal first quarter revenue from continuing ... million Fiscal first quarter adjusted income from continuing ... per share Fiscal first quarter GAAP income from ... share Rx segment revenue grew 47 percent with ...
Cached Medicine Technology:CareFusion Reports First Quarter Fiscal 2011 Results; Reaffirms Fiscal 2011 Financial Guidance 2CareFusion Reports First Quarter Fiscal 2011 Results; Reaffirms Fiscal 2011 Financial Guidance 3CareFusion Reports First Quarter Fiscal 2011 Results; Reaffirms Fiscal 2011 Financial Guidance 4CareFusion Reports First Quarter Fiscal 2011 Results; Reaffirms Fiscal 2011 Financial Guidance 5CareFusion Reports First Quarter Fiscal 2011 Results; Reaffirms Fiscal 2011 Financial Guidance 6CareFusion Reports First Quarter Fiscal 2011 Results; Reaffirms Fiscal 2011 Financial Guidance 7CareFusion Reports First Quarter Fiscal 2011 Results; Reaffirms Fiscal 2011 Financial Guidance 8CareFusion Reports First Quarter Fiscal 2011 Results; Reaffirms Fiscal 2011 Financial Guidance 9CareFusion Reports First Quarter Fiscal 2011 Results; Reaffirms Fiscal 2011 Financial Guidance 10Perrigo Reports Record Earnings and Raises Full Year Adjusted EPS Guidance 2Perrigo Reports Record Earnings and Raises Full Year Adjusted EPS Guidance 3Perrigo Reports Record Earnings and Raises Full Year Adjusted EPS Guidance 4Perrigo Reports Record Earnings and Raises Full Year Adjusted EPS Guidance 5Perrigo Reports Record Earnings and Raises Full Year Adjusted EPS Guidance 6Perrigo Reports Record Earnings and Raises Full Year Adjusted EPS Guidance 7Perrigo Reports Record Earnings and Raises Full Year Adjusted EPS Guidance 8Perrigo Reports Record Earnings and Raises Full Year Adjusted EPS Guidance 9Perrigo Reports Record Earnings and Raises Full Year Adjusted EPS Guidance 10Perrigo Reports Record Earnings and Raises Full Year Adjusted EPS Guidance 11Perrigo Reports Record Earnings and Raises Full Year Adjusted EPS Guidance 12Perrigo Reports Record Earnings and Raises Full Year Adjusted EPS Guidance 13Perrigo Reports Record Earnings and Raises Full Year Adjusted EPS Guidance 14Perrigo Reports Record Earnings and Raises Full Year Adjusted EPS Guidance 15Perrigo Reports Record Earnings and Raises Full Year Adjusted EPS Guidance 16Perrigo Reports Record Earnings and Raises Full Year Adjusted EPS Guidance 17Perrigo Reports Record Earnings and Raises Full Year Adjusted EPS Guidance 18Perrigo Reports Record Earnings and Raises Full Year Adjusted EPS Guidance 19
(Date:10/1/2014)... (PRWEB) October 01, 2014 Marriagelifeinsurance.com ... find life insurance for retired couples. , Senior ... provide financial security for their loved ones. A joint ... both insured persons pass away. , Life insurance ... expense life insurance can even be purchased online, as ...
(Date:10/1/2014)... October 01, 2014 Bedros Keuilian is ... Boot Camp fitness boot camps, he’s also considered the ... , with sold out business summits, a line of ... consultant to a recent Spike TV reality show to ... now is the time for personal trainers and fitness ...
(Date:10/1/2014)... First Warning Systems, a pioneer in early cancer ... body, announced the company is changing its name to ... of upcoming product releases. The initial focus will be ... initial focus will be an ‘Internet of Everthing,’ wearable ... changes over time,” said Rob Royea, president and CEO ...
(Date:10/1/2014)... and ATLANTA (PRWEB) October 01, 2014 ... security executive networking and relationship-marketing firm, announced ... Information Security Executive® and Project of the ... top-ranking decision makers representing organizations in financial ... Projects include large-scale technology endeavors that address ...
(Date:10/1/2014)... Join the more than 80 golfers who already have ... charity golf tournament to benefit Project HEAL, a not-for-profit organization ... afford treatment. The tournament will be held Monday, Oct. 6, ... The day-long event starts with 10:30 a.m. check-in and shotgun ... begin at 5 p.m. and will include an auction featuring ...
Breaking Medicine News(10 mins):Health News:Elderly Life Insurance - Find Life Insurance for Retired Couples! 2Health News:Bedros Keuilian Shares Tips on Selling Personal Training for the Holidays 2Health News:Bedros Keuilian Shares Tips on Selling Personal Training for the Holidays 3Health News:First Warning Systems Changes Name to Cyrcadia Health to Better Reflect Core Competency and Goals of Company 2Health News:First Warning Systems Changes Name to Cyrcadia Health to Better Reflect Core Competency and Goals of Company 3Health News:First Warning Systems Changes Name to Cyrcadia Health to Better Reflect Core Competency and Goals of Company 4Health News:T.E.N. Announces Nominees for the 2014 ISE® North America Awards; People’s Choice Award voting now open to industry at large 2Health News:T.E.N. Announces Nominees for the 2014 ISE® North America Awards; People’s Choice Award voting now open to industry at large 3Health News:T.E.N. Announces Nominees for the 2014 ISE® North America Awards; People’s Choice Award voting now open to industry at large 4Health News:T.E.N. Announces Nominees for the 2014 ISE® North America Awards; People’s Choice Award voting now open to industry at large 5Health News:T.E.N. Announces Nominees for the 2014 ISE® North America Awards; People’s Choice Award voting now open to industry at large 6Health News:T.E.N. Announces Nominees for the 2014 ISE® North America Awards; People’s Choice Award voting now open to industry at large 7Health News:Project HEAL Benefit Golf Tournament Gaining Momentum 2Health News:Project HEAL Benefit Golf Tournament Gaining Momentum 3
... type of hormone therapy used to treat advanced breast ... significant increase// in overall survival when compared to other ... studies. ,In addition, aromatase inhibitors — ... less likely to cause blood clots and vaginal bleeding ...
... identified a particular gene that influences how severe a ... that a different strategy// might be needed for treating ... than allergies. ,"What this shows is ... allergic asthma. Most people think asthma is asthma, but ...
... The Bioengineering Researchers at UC San Diego, reporting their ... painstakingly assembled// a virtual human metabolic network that will ... treatments for hundreds of human metabolic disorders, from diabetes ... ,This first-of-its-kind metabolic network builds on the ...
... oldest mother admitted to a British newspaper that she lied to ... deliver her babies. She// gave birth to twin sons named Pau ... 67 this month, lied by saying she was only 55, which ... said that she had to sell her house in Spain for ...
... has approved a new drug, named YAZ, which can be ... for treating acne.// ,The U.S. Food and Drug ... also treat emotional and physical symptoms of premenstrual dysphoric disorders. ... AG has become the first oral contraceptive approved by the ...
... There is both good and bad news in the report ... ,The report looks at figures representing cases of infection ... and the ‘super bug’ MRSA. ,According to the ... by 5.5 percent, which represents an increase to 42,625 from ...
Cached Medicine News:Health News:Hormone Drug Type Makes Survival Difference in Advanced Breast Cancer 2Health News:Hormone Drug Type Makes Survival Difference in Advanced Breast Cancer 3Health News:Different Treatments Needed For Breathing Problems 2Health News:Research on Human Metabolic Disorders 2Health News:Research on Human Metabolic Disorders 3Health News:Lethal Hospital Bug Tough to Knock Down, Statistics Reveal 2
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: